Summary

This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to
evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care
(BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following
autologous stem cell transplant (ASCT).

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria:
- Patients with HL who have received ASCT in the previous 30-45 days
- Patients at high risk of residual HL post ASCT
- Histologically-confirmed HL
- ECOG of 0 or 1
- Adequate organ function
Exclusion Criteria:
- Previous treatment with brentuximab vedotin
- Previously received an allogeneic transplant
- Patients who were determined to have a best clinical response of progressive disease
with salvage treatment immediately prior to ASCT
- History of another primary malignancy that has not been in remission for at least 3
years
- Post ASCT or current therapy with other systemic anti-neoplastic or investigational
agents

Additional Information

Official title

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma Following Autologous Stem Cell Transplant

Trial information was received from ClinicalTrials.gov and was last updated in March 2015.

Information provided to ClinicalTrials.gov by Seattle Genetics, Inc..

Location data was received from the National Cancer Institute and was last updated in April 2016.